Proton Therapy as a Case Study in Systems IntegrationEngineering, Regulatory, and Operations at the Frontier
A particle accelerator. A 100-ton rotating gantry. 20 major assemblies from across the globe. 50+ international safety standards as design inputs. One FDA 510(k) submission. This is what real systems integration complexity looks like—and what it teaches about every program that follows.
Beyond Compliance: How Strategic Risk Analysis Drives Value Creation in Medical Device Development
Risk analysis isn’t a checkbox — it’s a competitive moat. Companies that master ISO 14971’s layered approach (Hazard Analysis → DFMEA → PFMEA → UFMEA) prevent recalls, accelerate approvals, and build patient trust. Here’s how.